An 8 week extension to a randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus anamlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy - ND

• Conditions: Essential hypertension; MedDRA version: 6.1Level: PTClassification code 10015488

• Registration Number: EUCTR2005-001258-26-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1244

Inclusion Criteria

-MSSPB 8805;140 mmHg, and/or MSDBP 8805;90 mmHg and currently treated with either valsartan 320 mg/HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at visit C -written informed consent to partecipate in the extension study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Premature discontinuation in the core study or failure to comply with the core study protocol -Any patient that the investigator decides should not participate in the extension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the incremental rate in blood pressure control for those patients on valsartan 320 mg /HCTZ 25 mg and amlodipine 5/10 mg or amlodipine 10 mg/HCTZ 25 mg and valsartan 160/320 mg at Visit 7, week 18 and end of study Visit 8, week 22 ;Secondary Objective: To evaluate the overall number of patients who reached BP control on the valsartan compared to the amlodipine treatment strategy at end of study including the core and extension phase To evaluate safety and tolerability, measured by rate of adverse events between baseline Visit C, week 14 and end of study Visit 8, week 22 ;Primary end point(s): The study extension is designed to look at the additional blood pressure control MSSBP 140 mmHg and MSDBP 90 mmHg achieved by adding a third drug to the valsartan or amlodipine treatment strategy.